2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.072 Hossain Borghaei NACLC23 Abstract

PP01.072 Hossain Borghaei NACLC23 Abstract

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The study, titled "Randomized Phase-3 Study: Tarlatamab, a DLL3-targeting Bispecific T-cell engager (BiTE), Compared to Standard-of-Care in Relapsed Small Cell Lung Cancer (DeLLphi-304)," aims to evaluate the efficacy and safety of tarlatamab, a bispecific T-cell engager molecule, in patients with relapsed small cell lung cancer (SCLC). SCLC is a fast-progressing cancer that typically relapses after initial treatment, and there are limited treatment options for relapsed cases. Tarlatamab engages both T cells and delta-like ligand 3 (DLL3) on SCLC cells, resulting in the destruction of cancer cells by T cells.<br /><br />The study builds upon previous phase 1 and phase 2 trials that demonstrated manageable safety profiles and antitumor activity of tarlatamab in heavily pretreated relapsed SCLC patients. The phase 2 study showed a durable objective response rate (ORR) that exceeded the phase 1 trial and a more favorable safety profile. The results of the phase 2 trial serve as the basis for the phase 3 trial described in this study.<br /><br />The phase 3 trial, currently ongoing, is a global, open-label, randomized trial that aims to enroll 700 patients with relapsed SCLC after platinum-based first-line chemotherapy. Patients will be randomized to receive either tarlatamab or standard-of-care therapy (lurbinectedin, topotecan, or amrubicin). The primary objective of the trial is to compare the efficacy of tarlatamab with standard-of-care in prolonging overall survival. Secondary endpoints include the comparison of progression-free survival and patient-reported outcomes.<br /><br />To be eligible for the trial, patients must have histologically or cytologically confirmed relapsed SCLC, have measurable lesions, and adequate organ function. Exclusions include untreated or symptomatic central nervous system metastases and a history of severe immune-mediated adverse events or non-small cell lung cancer.<br /><br />The study is registered under NCT05740566 and is funded by Amgen Inc.

Keywords

Tarlatamab

Bispecific T-cell engager

Relapsed Small Cell Lung Cancer

Efficacy

Safety

Phase 3 trial

Overall survival

Progression-free survival

Patient-reported outcomes

Amgen Inc.